safety and tolerability of the pro-174 versus sophixín ofteno®, on the ocular surface of healthy subjects

Conditions: Conjunctivitis; Conjunctivitis, Bacterial

Summary: phase i clinical trial, to evaluate the safety and tolerability of the ophthalmic solution pro-174 versus sophixín ofteno®, elaborated by laboratorios sophia, s.a. of c.v. on the ocular surface of ophthalmologically and clinically healthy subjects. goals: to evaluate the safety and tolerability of the formulation pro-174 manufactured by laboratorios sophia, s.a. of c.v. on the ocular surface of clinically healthy subjects. hypothesis: the ophthalmic solution pro-174 presents a safety and tolerability profile similar to the comparator in healthy subjects.

phase i clinical trial, to evaluate the safety and tolerability of the ophthalmic solution pro-174 versus sophixín ofteno®, elaborated by laboratorios sophia, s.a. of c.v. on the ocular surface of ophthalmologically and clinically healthy subjects. goals: methodology: phase i clinical trial, controlled, of parallel groups, double blind, randomized, exploratory. number of patients: 30 subjects, divided into 2 groups \[15 subjects (30 eyes) exposed per group\] test product, dose and route of administration, lot number: * pro-174. levofloxacin 0.5% ophthalmic solution. prepared by laboratorios sophia, s.a. of c.v., zapopan, jalisco, mexico. * dosage: 1 drop every 2 hours during the waking period (8 daily applications), on day 1 and 2; continuing with 1 drop every 4 hours during the waking period (4 daily applications) from day 3 to 7. both eyes. * route of administration: ophthalmic duration of treatment: 7 days statistical methodology: the data will be expressed with measures of central tendency: mean and standard deviation for the quantitative variables. the qualitative variables will be presented in frequencies and percentages. the statistical analysis will be carried out through the mann-whitney u test for the quantitative variables for the difference between the groups. the intra-group difference will be made with the wilcoxon rank test. the difference between the qualitative variables will be analyzed by means of x2 (chi2). an alpha ≤ 0.05 will be considered significant.

Eligibility criteria:
inclusion criteria: * signed informed consent. * systemically and ophthalmologically healthy subjects evaluated during the clinical history. * age between 18 to 45 years. * both genders. * blood tests (complete blood count, blood chemistry of three elements and liver function tests) within normal parameters specified by the reference laboratory with a lower and upper margin of 10%. * vital signs within normal parameters. (vital signs at rest: blood pressure ≤ 139/89 mmhg, heart rate 60 -100 beats per minute and respiratory rate of 12-24 breaths per minute). * visual capacity 20/30 or better, in both eyes. * intraocular pressure ≥11 and ≤ 21 mmhg. exclusion criteria: general criteria * subjects with a history of hypersensitivity to any of the components of the research products. * subject users of topical ophthalmic medications of any pharmacological group. * subject users of medication by any other route of administration. * pregnant or lactating women. * women of childbearing age, who do not ensure a hormonal contraceptive method or intrauterine device during the study period or without a history of bilateral tubal obstruction, oophorectomy or hysterectomy; as fertile age we understand women who have not had their menopause, defined as 12 months since the last menstruation in women over 40 years. * subjects with participation in clinical research studies 90 days prior to inclusion in the present study. * diagnosis of liver disease or elevation to three times the normal upper value of any of the following liver enzymes: aspartate transferase (ast), alanine transferase (alt) or bilirubin. * inability to attend or answer the evaluations made in each of the visits. * positive smoking (specified as cigarette consumption regardless of amount and frequency) * positive alcoholism (specified as the consumption of alcoholic beverages, regardless of quantity and frequency, during the study intervention period). * contact lens users. * an occlusive iridocorneal angle, defined as a trabecular mesh visible at less than 90 ° from the angular circumference to gonioscopy.

Keywords: ocular antibiotic quinolone levofloxacin ophthalmic antibiotic antibiotic in drops